Celiac Disease
Conditions
Brief summary
This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.
Interventions
DRUGDONQ52
Subcutaneous (SC) injection
DRUGPlacebo
Subcutaneous (SC) injection
Sponsors
Chugai Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* History of medically diagnosed celiac disease based on biopsies and positive celiac serology. * Be on a GFD for at least 12 months * HLA-DQ2.5 genotype * Experienced at most mild symptoms of celiac disease
Exclusion criteria
* Refractory celiac disease * Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher | Up to 246 days | Incidence and severity of TEAEs and its relationship to the study drugs |
| Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation) | Up to 246 days | Abnormality in vital signs |
| Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate) | Up to 246 days | Abnormality in Electrocardiograms (ECGs) |
| Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis) | Up to 246 days | Incidence of laboratory abnormalities, based on clinical laboratory tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics; Time to maximum serum concentration [Tmax] | Up to 246 days | Tmax of DONQ52 |
| Pharmacokinetics; Half life [T1/2] | Up to 246 days | T1/2 of DONQ52 |
| Pharmacokinetics; Area under the serum concentration time curve [AUC] | Up to 246 days | AUC of DONQ52 |
| Immunogenicity | Up to 246 days | Prevalence and incidence of anti-drug antibodies (ADAs) to DONQ52 |
| Pharmacokinetics; Serum DONQ52 concentration | Up to 246 days | Serum DONQ52 concentrations over time |
| Pharmacokinetics; Maximum serum concentration [Cmax] | Up to 246 days | Cmax of DONQ52 |
Countries
Australia, United States
Outcome results
None listed